Anti T-lymphocyte Immunoglobulin With Post Transplant Cyclophosphamide to Prevent GVHD Post Allogeneic Transplantation

Graft Versus Host Disease Clinical Trial

Official title:

A Phase II Study of Neovii Anti-human T-lymphocyte Immunoglobulin (ATLG, Grafalon®) With Post Transplant Escalated Doses of Post-transplant-Cyclophosphamide to Prevent Acute and Chronic GVHD Post Allogeneic Stem Cell Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03357159
• Other study ID #: SHEBA-17-4055-AN-CTIL
• Status: Recruiting
• Phase: Phase 2
• Start date: September 6, 2018
• Est. completion date: December 1, 2024

Study information

• Verified date: November 2023
• Source: Sheba Medical Center
• Contact: Arnon Nagler, MD
• Phone: 972-3-530-58-30
• Email: Arnon.Nagler[@]sheba.health.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Investigators hypothesize that combination of ATLG with PTCy in matched or mismatched unrelated hematopoietic stem cell transplantation will reduce acute and chronic GVHD incidence. Furthermore it will allow shortening of the length of post-transplantation immunosuppression with calcineurin inhibitor (CNI) administration (currently administrated in addition to ATG as GVHD prophylaxis in daily common practice)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients with MDS/AML

2. 18 years or older and willing and able to comply with the protocol requirements.

3. LVEF = 40%. 2-D transthoracic echocardiogram (ECHO) is the preferred method of evaluation. Multigated Acquisition Scan (MUGA) is acceptable if ECHO is not available.

4. Patients undergoing 8-10/10 HLA matched unrelated and unmanipulated PBSC transplantation

5. Patients conditioned with reduced intensity or reduced toxicity conditioning of fludarabine with reduced dose (2 days) or myeloabalative doses (4 days) of busulfan or with treosulfan.

6. Patients must sign written informed consent.

7. Adequate birth control in fertile patients.

Exclusion Criteria:

1. Patients undergoing other type of transplantation or with other type of basic disease other than AML or MDS.

2. Patients with respiratory failure (DLCO < 30%).

3. Active congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention.

4. Psychiatric conditions/disease that impair the ability to give informed consent or to adequately co-operate

5. Bilirubin > 3.0 mg/dl, transaminases > 3 times upper normal limit

6. Creatinine > 2.0 mg/dl

7. ECOG-Performance status > 2

8. Uncontrolled infection

9. Pregnancy or lactation

10. CNS disease involvement

11. Pleural effusion or ascites > 1 liter.

Related Conditions & MeSH terms

• Graft Versus Host Disease
• Graft vs Host Disease

Intervention

Drug:
• Cyclophosphamide
In the first phase escalated doses of post-transplant cyclophosphamide up to a maximal dose of 50 mg/kg , the second phase will use the MTD cyclophosphamide dose identified in the first phase.
• anti-human T-lymphocyte immunoglobulin (ATLG)
15mg/kg total (5mg/kg day) on days -3 to -1 pre transplantation

Locations

Country	Name	City	State
Israel	Chaim Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overal survival	Overall survival will be calculated from the day of SCT until death or last follow-up. OS will be determined using Kaplan-Meyer product limit method.	24 months
Primary	Disease-free survival	Disease-free survival will be calculated from the day of SCT until relapse, death of any cause, or last follow-up. DFS will be determined using Kaplan-Meyer product limit method.	24 months